MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH; PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL

Model Number G8292035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional (hcp) via manufacturer representative regarding a post-op event for a patient diagnosed with stenosis at l3/5, who underwent plf at l1/2/3.It was reported that vertebral body of l2 had collapsed post-op and revision surgery of plf was performed at l1/3.No device malfunction was alleged.The product was explanted, and it was replaced with medtronic product.Health injury was reported in the patient.

• Brand Name: TSRH
• Type of Device: PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10222747
• MDR Text Key: 197337648
• Report Number: 1030489-2020-00774
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2017
• Device Model Number: G8292035
• Device Catalogue Number: G8292035
• Device Lot Number: 0015443W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Date Device Manufactured: 02/27/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR